Galderma Receives FDA Approval for AKLIEF® (trifarotene) Cream, 0.005%, the First New Retinoid Molecule for the Treatment of Acne in Over 20 Years

Next-Generation Treatment is First Option Studied and Proven Effective in Both Facial and Truncal Acne

FORT WORTH, Texas – (October 4, 2019) – Galderma, a global leader focused on meeting the world’s increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. AKLIEF Cream is the only topical retinoid that selectively targets retinoic acid receptor (RAR) gamma, the most common RAR found in the skin.[1],[2],[3]Trifarotene is the first new retinoid molecule to receive U.S. FDA approval for the treatment of acne in more than 20 years.[4],[5],[6] AKLIEF Cream is the first topical treatment specifically studied and proven to treat both facial (forehead, cheeks, nose and chin) and truncal (chest, shoulders and back) acne, offering healthcare professionals and acne patients another treatment option.1

The FDA approval of AKLIEF Cream is supported by data from the two pivotal Phase 3 clinical trials of once-daily AKLIEF Cream in patients with moderate acne on the face and trunk.1 The two identical 12-week, randomized, multicenter, parallel group, double-blind, vehicle-controlled clinical trials of 2,420 patients showed that AKLIEF Cream significantly reduced inflammatory lesions as early as two weeks on the face and four weeks on the back, shoulders and chest compared to vehicle (p<0.05).1 AKLIEF Cream was well tolerated when used on the face, back, shoulders and chest.1 The most common adverse reactions (incidence>1%) included application site irritation, application site pruritus (itching) and sunburn.1

“The approval of AKLIEF Cream underscores our ability to bring new active molecules to the community, and innovate even in well-established therapeutic classes. It is consistent with our intent to change the paradigm of how even the most common and frustrating skin diseases are treated, including acne,” said Thibaud Portal PhD, Galderma Global Vice President, Prescription. “We are pleased to add this new treatment option, with proven efficacy in facial and truncal acne, to our innovative and differentiated portfolio of acne treatments.”

AKLIEF Cream is expected to be available in the United States in November 2019. It will be provided in a 45 gram pump. Galderma is working closely with payers, providers and pharmacy benefit managers to ensure broad and rapid access to AKLIEF Cream. The company will also offer a patient savings card program, Galderma CareConnect*.

Acne is the most common skin disease in the United States, affecting up to 50 million Americans annually and approximately 85% of young people.[7] An inflammatory disease, acne occurs when a combination of sebum (oil) and dead skin cells clog pores, allowing the bacteria associated with acne (p. acnes) to grow.7,[8] Acne on the face is the most common and often the most visible presentation of the disease. More than half of people with facial acne (52%) also have truncal acne.[9] Adult acne tends to affect women more often than men and adult-onset acne is becoming increasingly common in women in their 20s and beyond.[10] Back acne, once thought to be a predominantly male disease, has been shown to be prevalent in females.910 Acne can trigger feelings of depression, poor body image and low self-esteem.[11]

AKLIEF Cream U.S. Important Safety InformationIndication: AKLIEF® (trifarotene) Cream, 0.005% is a retinoid indicated for the topical treatment of acne vulgaris in patients 9 years of age and older. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with AKLIEF Cream were application site irritation, application site pruritus (itching), and sunburn. Warnings/Precautions: Patients using AKLIEF Cream may experience erythema, scaling, dryness, and stinging/burning. Use a moisturizer from the initiation of treatment, and, if appropriate, depending upon the severity of these adverse reactions, reduce the frequency of application of AKLIEF Cream, suspend or discontinue use. Avoid application of AKLIEF Cream to cuts, abrasions or eczematous or sunburned skin. Use of “waxing” as a depilatory method should be avoided on skin treated with AKLIEF Cream. Minimize exposure to sunlight and sunlamps. Use sunscreen and protective clothing over treated areas when exposure cannot be avoided.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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